Ganciclovir sodium: adverse event reports filed with FDA

568

reports as suspect product

0% of all reports · about 25 a year

86

reports, 12 months to June 2026

73 in the 12 months before

96.5%

marked serious by the reporter

94.2% across the class

39.1%

record death among outcomes, as reported

222 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Ganciclovir sodium reports recording the termmedian drug in cytomegalovirus nucleoside analog dna polymerase inhibitor

1. Off label useused for a purpose or in a way not on the label26.2%149
2. Drug ineffectivethe medicine did not work as expected17.1%97
3. Drug ineffective for unapproved indication10.4%59
4. Neutropenialow neutrophils, a type of white blood cell9.9%56
5. Cytomegalovirus infection9.5%54
6. Drug resistance9.2%52
7. Condition aggravatedthe condition being treated got worse5.5%31
8. Product use in unapproved indicationused for a purpose not on the label5.5%31
9. Pancytopenialow counts of all blood cells3.3%19
10. Treatment failurethe treatment did not work3.2%18
11. Myelosuppression3%17
12. Aspergillosis2.8%16
13. Cytomegalovirus infection reactivation2.6%15
14. Leukopenialow white blood cells2.6%15
15. Cytomegalovirus chorioretinitis2.3%13
16. Multiple organ dysfunction syndromeseveral organs failing2.3%13
17. Renal impairmentreduced kidney function2.3%13
18. Stenotrophomonas infection2.3%13
19. Thrombocytopenialow platelets2.1%12
20. Brain oedema1.9%11
21. End stage renal diseasekidney failure needing dialysis or transplant1.9%11
22. Enterococcal infection1.9%11
23. Respiratory failurethe lungs could not supply enough oxygen1.9%11
24. Blood pressure fluctuation1.8%10
25. Brain abscess1.8%10
26. Cytomegalovirus colitis1.8%10
27. Fusarium infection1.8%10
28. Intracranial infection1.8%10
29. Nephropathy toxic1.8%10
30. Renal failurekidney failure1.8%10

Top 30 of 171 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 5 drugs in the cytomegalovirus nucleoside analog dna polymerase inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 14,000 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 24.1% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 568 reports.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the cytomegalovirus nucleoside analog dna polymerase inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Ganciclovir sodium as a suspect or interacting product; reports listing it only as a concomitant medication (139) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.